Host Response to Infection and Treatment in Lymphatic Filarial Disease in India

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by National Institutes of Health Clinical Center (CC).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00342576
First received: June 19, 2006
Last updated: November 20, 2012
Last verified: December 2011

June 19, 2006
November 20, 2012
April 1994
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Complete list of historical versions of study NCT00342576 on ClinicalTrials.gov Archive Site
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Host Response to Infection and Treatment in Lymphatic Filarial Disease in India
Host Response to Infection and Treatment in Lymphatic Filarial Disease in India

Patients admitted on this protocol will have, or be suspected of having, one of the lymphatic filarial infections affecting humans. After routine clinical evaluation they will be studied in depth immunologically, and their blood cells and/or serum will be collected to provide reagents (eg., specific antibodies, T cell clones, etc.) that will be used in the laboratory to address the broader questions of immunodiagnosis, immunoregulation, immunopathology and immunoprophylaxis. Careful observations of the patients' clinical and immunologic responses to therapy will be made, as well as long-term follow-up of these changes. It is anticipated both that the patients will receive optimal clinical care for their infections and that the specimens collected from them will prove to be valuable reagents for the laboratory studies of the immunologic responses unique to filarial or other helminthic infections.

This study is designed to determine the presence of and the immune response to filarial infections in an area endemic for lymphatic filariasis in South India. This study will aim to examine the presence of filarial infection at a community level as well as in hospital settings. After routine clinical evaluation and screening, individuals enrolled in this protocol will be studied in depth immunologically, and their blood cells and/or serum will be collected to address the broader questions of immunodiagnosis, immunoregulation, immunopathology and immunoprophylaxis. Careful observations of the individuals' clinical and immunologic responses to therapy will be made, as well as long-term follow-up of these changes. In addition to infected individuals, this protocol will also be used to study individuals with filarial pathology and endemic normal individuals. This will enable us to characterize the immunological profiles of infected, uninfected and diseased individuals in an endemic area and provide greater insight into the pathogenesis of lymphatic filarial disease.

Observational
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Lymphatic Filarial Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
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  • INCLUSION CRITERIA:

Age 18-75 years.

Ability to give informed consent.

EXCLUSION CRITERIA:

Pregnant or nursing women will be excluded from the treatment arm of the study.

Less than 18 years of age; greater than 75 years of age.

Both
18 Years to 75 Years
No
Contact: V. Kumaraswami, Ph.D. Not Listed
Contact: Thomas B Nutman, M.D. (301) 496-5398 tnutman@niaid.nih.gov
India
 
NCT00342576
9999890048, OH89-I-0048
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National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Thomas B Nutman, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP